EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

MICROPORT ORTHOPEDICS INC.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Evolution Mp Cs/cr Porous Femur/evolution Adaptive Cs And Ps Inserts.

Pre-market Notification Details

Device IDK140735
510k NumberK140735
Device Name:EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington,  TN  38002
ContactCaroline Fryar
CorrespondentCaroline Fryar
MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington,  TN  38002
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-24
Decision Date2014-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00192629082588 K140735 000

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